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For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Norfloxacin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This document is a FDA 510(k) clearance letter for the "System U3 for Norfloxacin". It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not contain the acceptance criteria or a study describing the device's performance against such criteria.

The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance data. Therefore, I cannot provide the requested information from this document.

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